TENA PROSKIN BARRIER

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: TENA PROSKIN BARRIER
Generic name: DIMETHICONE
Manufacturer: Essity HMS North America Inc
Product type: HUMAN OTC DRUG
SPL set ID: 118bf2df-ee7b-454f-9c0b-2697dc826268
SPL ID: 467a1ea7-0abf-bd8a-e063-6394a90ae073
Version: 9
Effective date: 2025-12-21
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:27:25

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 10 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M016	openfda.application_number
brand name		TENA PROSKIN BARRIER	openfda.brand_name
generic name		DIMETHICONE	openfda.generic_name
manufacturer name		Essity HMS North America Inc	openfda.manufacturer_name
ndc	package	59608-006-01	openfda.package_ndc
ndc	product	59608-006	openfda.product_ndc
ndc11	package	59608000601	derived:openfda.package_ndc
spl id		467a1ea7-0abf-bd8a-e063-6394a90ae073	id
spl set id		118bf2df-ee7b-454f-9c0b-2697dc826268	set_id
unii		92RU3N3Y1O	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS For external use only. Do not use on deep or puncture wounds on animal bites on serious burns When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.